Sep 12, 2024 FDA Serves Up a Stricter Enforcement Standard for Celebrities Endorsing Rx Drugs By Jim Czaban Being a celebrity has its challenges. Adding a new one to the list, the U.S. Food and Drug Administration (FDA) has recently issued an...
Aug 21, 2024 Allergan Holding Protects "First-Filed" Parent Patents from Their Misbehaving Patent Offspring By Jonathan B. Thielbar This month, in Allergan USA, Inc. v. MSN Laboratories Private Ltd., the Federal Circuit added to the ongoing patent-family drama...
May 14, 2024 GSK Joins COVID-19 mRNA Vaccine Patent War By Dan Liu mRNA-Based Vaccine and Other Therapeutics mRNA-based vaccines have become one of the most discussed technologies both inside and outside...
Apr 25, 2024 Amending ANDA by Purportedly Carving Out Infringing Use—After Trial—Does Not Rescue the Amended ANDA from the Negative PIV Judgment By Dan Liu The district court in Salix Pharmaceuticals, Ltd. et al v. Norwich Pharmaceuticals, Inc., Civil Action No. 20-430-RGA (D. Del.) was asked...
Mar 13, 2024 Are FDA Astronauts Coming Soon? Implications of the Revolution in Space-Based Drug Manufacturing By Jim Czaban Recent news reports have described the successful progress of at least one company, Varda Space Industries, in developing a space-based...
Jan 31, 2024 Lessons Learned: FDA Digs Up, and Discards, Time-Capsule Citizen Petition Re: Online Drug and Device Promotion By Jim Czaban The FDA Citizen Petition ("CP") process is a widely used, but often seemingly fruitless tool by which interested persons and entities can...
Dec 04, 2023 The Perils of Incorporation by Reference at the Federal Circuit By Ryan Hagglund Because judicial resources are limited, virtually all courts impose length limitations, such as word, page, or line limits, for briefing....
Nov 15, 2023 FDA's First Interchangeable Biosimilar Exclusivity Decision -- Prelude to a New Wave of FDA Litigation? By Jim Czaban FDA has released an 18-page internal decision memo which for the first time lays out the agency's interpretation of how regulatory...
Nov 14, 2023 Demand for Weight Loss Drugs: Pounds Drop, but Counterfeit-Related Hospitalizations Rise By Kristen R. Klesh Melanie J. Howard Admittedly, the topic of weight loss isn't the ideal “Turkey-Day” conversation starter. Nevertheless, when the discussion relates to a...
Nov 13, 2023 Federal Circuit Requires Analysis of Extrinsic Evidence in Construction of "a pH of 13" By Ryan Hagglund Earlier this week, in Actelion Pharmaceuticals Ltd. v. Mylan Pharmaceuticals Inc., No. 22-1889, 2023 U.S. App. LEXIS 29433 (Fed. Cir....
Nov 08, 2023 FTC's New Orange Book Listing Complaints Target Drug Delivery Device Patent Issue That FDA Has Ignored For Years By Jim Czaban The Federal Trade Commission (FTC) is at it again, jumping into the Food and Drug Administration's sandbox with a splashy press release...
Nov 06, 2023 Risk of Patent Infringement Unprotected by the Hatch-Waxman Safe Harbor in Cell-Based Therapeutic Product Development By Ryan Hagglund The advent of cell-based therapeutics, such as chimeric antigen receptor T-cells (“CAR-T cells”), as well as their development and...